Disintegrating particle composition produced by a two-stage wet granulation process and orally disintegrating tablet containing the composition

摘要

An object of the present invention is to provide a disintegrative particulate composition that can be used for an orally disintegrating tablet having both excellent tablet hardness and disintegrability. This invention relates to a method for the production of a disintegrative particulate composition including three components consisting of a first disintegrator component having sedimentation volume in water of 4.0 cm3/g or more, a second disintegrator component other than the first disintegrator component and an excipient, which comprises a first wet granulation step using any two of the three components and a second wet granulation step using the granules obtained in the first wet granulation step and at least the remaining one component not used in the first wet granulation step; the disintegrative particulate composition thus produced; and an orally disintegrating tablet comprising a medicinal ingredient and the disintegrative particulate composition.